Clinical Research Medical Director, Neuroscience

Employer
Amgen
Location
Thousand Oaks, California
Posted
Oct 05, 2018
Ref
R-63425
Required Education
Bachelors Degree
Position Type
Full time

The Neuroscience Therapeutic Area is seeking a Clinical Research Medical Director for a global, high priority neuroscience program in migraine prophylaxis. This role will have an opportunity to shape the growing Neuroscience Therapeutic Area and will report to the Global Development Leader (GDL), who in turn reports to the VP, Neuroscience.

Responsibilities:

Supporting the strategic development, execution and communication of the global evidence generation plan

Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program

Supporting the development of key scientific external relationships with opinion leaders

Participating and providing clinical input into safety and regulatory interactions

Key Activities:

Provide clinical/scientific input into new studies, beginning with early concept generation and extending to protocol development and execution of clinical trials

Interpret clinical trial data

Participate in safety assessments

Participate in interactions with regulatory agencies

Author CSRs, publications and regulatory submissions

Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL

Identify new clinical research opportunities

Support in-licensing and out-licensing activities and partner relationships

Support product lifecycle management for new indications as directed by Global Development Leader

Provide clinical content input to:

  • Regulatory interactions and documents
  • Safety interactions and documents
  • Materials to be used in Scientific Affairs

#LI-POST

MD01

Basic Qualifications

MD or DO degree from an accredited medical school

AND

3 years of clinical research in the biopharmaceutical industry

Preferred Qualifications

Board certified in relevant therapeutic area

5 years of clinical research in the biopharmaceutical industry, preferably in Neuroscience

Knowledge:

In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

Familiarity with concepts of clinical research and clinical trial design, including biostatistics

Sound scientific and clinical judgment

Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements

Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

Demonstrated ability as a medical expert in a complex matrix environment

History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.